title: Large scale chiral chromatography for the separation of an enantiomer to accelerate drug development.
abstract: There are several approaches to produce enantiomerically pure drug substances, such as recrystallization, catalytic process (ligand and enzyme), indirect chromatographic resolution, and direct chromatographic resolution. However, the use of preparative chromatography with chiral stationary phases seems to be most effective for early phase projects, where the time and resources on the developments need to be minimized to get the drug candidates into the clinical studies. We showed that by following a well-defined process, chiral chromatography can be easily scaled up from an analytical system to a pilot plant system. We also used the results from a multicolumn continuous chromatography (MCC) study to conclude that MCC can be a cost-effective production method for chiral manufacturing.
authors.affiliation: Product Development, GlaxoSmithKline, Platform Technology and Science, King of Prussia, Pennsylvania 19406, USA. leo.hsu@gsk.com
authors.forename: Leo C
authors.initials: LC
authors.lastname: Hsu
authors.forename: Hyunjung
authors.initials: H
authors.lastname: Kim
authors.forename: Xiqin
authors.initials: X
authors.lastname: Yang
authors.forename: David
authors.initials: D
authors.lastname: Ross
mesh_terms: D002845:Chromatography / Q000379:methods; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation*; D003362:Cost-Benefit Analysis; D055808:Drug Discovery / Q000191:economics; D004526:Efficiency; D008024:Ligands; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000302:isolation & purification*; D013237:Stereoisomerism; D014894:Weights and Measures
chemical_list: D008024:Ligands; D004364:Pharmaceutical Preparations